Gibbons Law Alert

Gibbons Law Alert

Tagged: Patent Prosecution

Baxalta Inc. v. Genentech, Inc.: The Federal Circuit Addresses Enablement After Amgen v. Sanofi

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Posted in Biotech / Patent / Pharmaceuticals

On September 28, 2023

Baxalta Inc., v. Genentech, Inc., Appeal No. 2022-1461 (Fed. Cir. Sept. 20, 2023) is another in the line of cases where claims to biological compounds are drafted functionally and raise §112 issues. This decision was an appeal from a grant of summary judgment that held certain claims of Baxalta’s ‘590 patent invalid for lack of enablement. The technology involved antibodies for enhancing the mechanism for blood clotting to treat patients with hemophilia type A. Claim 1 of the patent recited “[a]n isolated antibody or antibody fragment thereof that binds Factor IX or Factor IXa and increases the procoagulant activity of Factor IXa.” (Emphasis added). The claim is drafted functionally; it describes what the antibody does, rather than what the antibody actually is, and it encompasses any antibody capable of achieving that function. The specification of the ‘590 patent disclosed only 11 actual antibodies that fell within the claim’s scope, and referred to generally known methods for producing and screening antibodies. Relying on the analysis provided by the Supreme Court’s recent decision, Amgen Inc. v. Sanofi, 598 U.S. 594 (2023), the court found that the ‘590 patent’s specification simply provided a roadmap for one to engage in the same iterative, trial-and-error process that the inventors used to find their 11 antibodies. It did not identify any common...

Artificial Intelligence System Cannot Be Listed as Inventor

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Posted in Patent / USPTO

On August 8, 2022

On Friday, the Federal Circuit held that the Patent Act requires an inventor to be a natural person, in response to a patent applicant who alleged that an artificial intelligence system was the inventor of a patent application. Thaler v. Vidal, No. 2021-2347, 2022 WL 3130863 (Fed. Cir. Aug. 5, 2022). The patent applicant, Stephen Thaler, asserted that he develops and runs artificial intelligence systems that generate patentable inventions. Mr. Thaler then sought patent protection through two patent applications and listed the artificial intelligence system as the inventor. After the U.S. Patent and Trademark Office (USPTO) denied the patent applications for failure to identify a valid inventor, Mr. Thaler and the USPTO adjudicated the matter in the U.S. District Court for the Eastern District of Virginia. The District Court found that the Patent Act requires an inventor to be a natural person. Thaler v. Hirshfeld, 558 F. Supp. 3d 238, 249 (E.D. Va. 2021), aff’d sub nom. Thaler v. Vidal, No. 2021-2347, 2022 WL 3130863 (Fed. Cir. Aug. 5, 2022). In affirming the District Court’s decision, the Federal Circuit first indicated that it need not perform an “abstract inquiry into the nature of invention or the rights, if any, of AI [artificial intelligence] systems.” Rather, the court began and ended on the “applicable definition in...

Increasing Patent Damage Awards with Pre-Judgment Interest

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Posted in Licensing / Patent

On June 23, 2022

In VLSI Technology LLC v. Intel Corporation, the United States District Court for the Western District of Texas recently awarded pre-judgment and post-judgment interest on a jury’s damage award in a patent infringement case. An issue examined by the court was whether the patentee was entitled to pre-judgment interest during periods in which the patentee did not own the patent. The defendant argued that since the patentee only acquired the patent rights in December 2018 and was not formed as an entity until 2016, pre-judgment interest from 2013 would be a windfall. The court dismissed this argument and indicated that the patentee “acquired the Asserted Patents and is therefore entitled to all the rights associated with patent ownership, including the rights to collect damages and interest from infringers.” The court then awarded pre-judgment interest beginning on the date of infringement (i.e., 2013) to the date of judgment. In support of this holding, the court cited the Federal Circuit’s decision in Energy Transp. Grp., Inc. v. William Demant Holding A/S, 697 F.3d 1342, 1358 (Fed. Cir. 2012) stating that “award of pre-judgment interest is the rule, not the exception.” The court also noted that there was no exceptional circumstances such as an undue delay in filing the lawsuit that would warrant denying pre-judgment interest in this...

New Jersey’s Patent Filings Place It Fifth in the Nation for Innovation

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Posted in Patent / USPTO

On December 8, 2020

NJBIZ recently reported on a study from CommericalCafe that named New Jersey the fifth most innovative state based on the number of patents filed and granted in New Jersey from 1975 through 2019. Of those patents, New Jersey’s top sections were: (1) Chemistry and Metallurgy, (2) Electricity, (3) Human Necessities, (4) Physics, and (5) Emerging Cross-Sectional Technologies. New Jersey’s standing is not limited to the acquisition of patent rights, but includes the enforcement and protection of those rights as well. This year, the Administrative Office of the U.S. Courts reported that the United States District Court for the District of New Jersey ranks seventh in the nation for the number of intellectual property cases filed in the 12-month period ending on March 31, 2020. Given the importance of development and enforcement of intellectual property rights in New Jersey, Gibbons P.C.’s Intellectual Property Department, headquartered in Newark, New Jersey, is routinely called on to represent its New Jersey clients in handling both patent prosecution and litigation across a vast number of industries.

Northern District of California Relies on the Safe Harbor Defense of Section 271(e)(1) to Resolve Infringement Cases Early

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Posted in Biotech / Pharmaceuticals

On November 30, 2020

Two recent decisions from the Northern District of California show courts’ willingness to dispose of cases early in litigation through the safe harbor defense. The safe harbor of Section 271(e)(1) allows competitors, before the expiration of a patent, to engage in otherwise infringing activities if the use is “reasonably related to” obtaining regulatory approval. These two decisions provide pre-litigation and litigation guidance for life science companies that manufacture regulated products such as drugs and medical devices. The Supreme Court has construed the safe harbor to apply to drugs as well as medical devices and other products subject to Food and Drug Administration (FDA) approval. Section 271(e)(1) of the Patent Act provides that: “It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention … solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.” In Carl Zeiss Meditec v. Topcon Medical Systems, the N.D. Cal. granted with prejudice a motion to dismiss the plaintiff’s patent infringement claim based on product testing as barred by the safe harbor of § 271(e)(1). Carl Zeiss alleged that software testing by Topcon...

USPTO Final Rule Limits a Reduction of Patent Term Adjustment to the Period the Applicant Failed to Undertake Reasonable Prosecution Efforts

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Posted in Licensing / Patent / USPTO

On June 26, 2020

On June 16, 2020, the United States Patent and Trademark Office (USPTO) published a final rule revising patent term adjustment under 35 U.S.C. 154(b) in view of Supernus Pharm., Inc. v. Iancu. In Supernus, the Federal Circuit held that a reduction of patent term adjustment must be equal to the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution of the application. The USPTO thus cannot deduct an amount of time beyond the period during which the applicant failed to undertake reasonable efforts to conclude prosecution. The USPTO revised relevant provisions pertaining to reduction of patent term adjustment, aligning the provisions with Federal Circuit law. Section 154(b)(2)(C) of the Patent Act authorizes the USPTO to reduce the total amount of patent term adjustment for certain delays by deducting the number of days equal to the period of time that “the applicant failed to engage in reasonable efforts to conclude prosecution of the application.” The USPTO implemented this section with 37 CFR § 1.704. In 2006, Supernus Pharmaceuticals filed patent applications in both the United States and Europe covering an osmotic drug delivery system. In February 2011, Supernus filed a Request for Continued Examination (RCE) in the U.S. application after a final rejection. Supernus’s European application was granted later...

Senator Sasse Proposes Legislation Extending the Patent Term for Inventions Intended to Treat COVID-19

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Posted in Biotech / USPTO

On April 6, 2020

On March 30, 2020, Senator Ben Sasse, R-Neb., introduced a bill that would create the Facilitating Innovation to Fight Coronavirus Act. The first part of the legislation would shield healthcare providers from federal, state, and local civil liability if they are testing or treating coronavirus patients in certain circumstances. The second part of the bill would extend patent protection for new and existing medical devices and drugs intended to treat COVID-19. The added patent protection under the bill would only apply to eligible patents. An eligible patent is “a patent issued for a new or existing pharmaceutical, medical device, or other process, machine, manufacture, or composition of matter, or any new and useful improvement thereof used or intended for use in the treatment of the Coronavirus Disease.” The bill proposes that the term for new eligible patents “not begin until the date on which the national emergency declared by the President …terminates.” Moreover, the bill provides that the term for an eligible patent “shall extend for 10 years longer than it otherwise would under [the Patent Act].” Thus the bill would enhance patent protection for inventions covering technologies created to treat the coronavirus and inventions covering existing technologies adapted to treat the coronavirus. The CARES Act, enacted on March 27, 2020, provides $140.4 billion in...

USPTO Waives Certain Deadlines in Light of the Coronavirus Outbreak

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Posted in Patent / USPTO

On April 3, 2020

On March 31, 2020, the United States Patent and Trademark Office (“USPTO”) issued a notice permitting 30-day extensions to the time allowed to file certain patent-related documents and to pay certain required fees. Gibbons previously analyzed the first USPTO coronavirus guidance. For this second guidance, the USPTO determined, under the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”), that the COVID-19 “emergency has prejudiced the rights of applicants, patent owners, or others appearing before the USPTO in patent matters, and has prevented applicants, patent owners, or others appearing before the USPTO in patent matters from filing a document or fee with the Office.” The USPTO thus provided parties with the ability to extend certain patent deadlines if the party is personally affected by the COVID-19 outbreak. The USPTO notice expressly provides that three Patent Trial and Appeal Board (PTAB) deadlines may be extended for 30 days upon request: a request for rehearing of a PTAB decision; a petition to the Chief Judge under 37 C.F.R. § 41.3; and a patent owner preliminary response in a trial proceeding. “For all other situations, a request for an extension of time where the COVID-19 outbreak has prevented or interfered with a filing before the Board can be made by contacting the PTAB.” Relief under the notice is...

Legislators Propose Framework To Reform Patent Eligibility Under Section 101

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Posted in Biotech / Patent / Pharmaceuticals

On May 2, 2019

On April 17, 2019, Senators Chris Coons and Thom Tillis, and Representatives Doug Collins, Hank Johnson, and Steve Stivers unveiled a framework to reform 35 U.S.C. §101. Section 101 of the Patent Act currently makes patentable “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” Although the statute is relatively permissive, courts have limited patentable subject matter beyond the statutory mandate by creating judicial exceptions. Under these exceptions as articulated in Alice Corp. v. CLS Bank International, “[l]aws of nature, natural phenomena, and abstract ideas are not patentable.” The proposed framework seeks to address these exceptions to patent eligible subject matter through statute versus an ever-growing list of case law. Under the lawmakers’ proposed framework, reformed Section 101 would: Keep existing statutory categories of process, machine, manufacture, or composition of matter, or any useful improvement thereof. Eliminate, within the eligibility requirement, that any invention or discovery be both “new and useful.” Instead, simply require that the invention meet existing statutory utility requirements. Define, in a closed list, exclusive categories of statutory subject matter which alone should not be eligible for patent protection. The sole list of exclusions might include the following categories, for example: Fundamental scientific principles Products that exist solely and exclusively in nature Pure...

PTAB Tackles Patentability Issues After New Guidelines

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Posted in Patent

On March 4, 2019

Recently, the United States Patent and Trade Office (USPTO) enacted new guidelines to “clarify” the patentability standard and analyses. The USPTO stated that it had undertaken this clarification because many court decisions on the issue of patentability of method type patents in the computer arena had become very difficult for examiners to understand and apply in a predictive manner. As such, there were concerns that the examining corp was not reaching consistent examination and prosecution results. Following the enactment of the new guidelines, a Patent Trial and Appeal Board (PTAB) panel reviewed four patents relating to methods of electronically storing financial documents. The patents involved were US Patents 6,963,866, 7,552,118, 7,836,067 and 9,141,612 belonging to Mirror Imaging LLC (Mirror). Those patents were challenged by Fidelity Information Services LLC (Fidelity) because Fidelity asserted that only abstract ideas were involved, thereby being unpatentable subject matter under section 101. In fact, in a previous PTAB challenge on the same four patents, the PTAB actually opined that the Mirror patents were likely invalid. At the hearing, the questioning by the administrative patent judges centered around whether the abstract ideas are “integrated into a practical application.” Answers to the question of the practical application revolved around the elimination of manually arranging and documenting financial information, as well as the improvement...

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